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Additional User Fee Funding Will Boost Global Harmonization, Says FDA’s Torres

 
• By Brian Bossetta

Recently passed legislation that includes higher medical device user fees will allow the US FDA to put more resources into establishing global harmonization standards with international partners.

International business concept with businessman and digital map superimposed on a city skyline background.
• Source: Shutterstock

During a panel on global regulatory convergence at the annual MedTech Conference in Boston, Melissa Torres of the US Food and Drug Administration’s device center discussed some of the implications of the Medical Device User Fee Amendment, or MDUFA V, on harmonizing international regulatory standards for medical devices.

Torres, associate director for international affairs at the FDA’s Center for Devices and Radiological Health (CDRH), said increased MDUFA V...

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